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Sirolimus Pregnancy and Breastfeeding Warnings

Sirolimus is also known as: Rapamune

Sirolimus Pregnancy Warnings

Sirolimus has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity and fetotoxicity. There are no controlled data in human pregnancy. The manufacturer recommends use effective contraception in women of childbearing age before, during, and for 12 weeks after the completion of sirolimus therapy. Sirolimus should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Azoospermia has been reported with the use of sirolimus and has been reversible upon discontinuation of sirolimus in most cases.

Sirolimus Breastfeeding Warnings

Sirolimus is excreted in the milk of lactating rats.

There are no data on the excretion of sirolimus into human milk. Because many drugs are excreted into human milk and because of the potential for adverse reactions to sirolimus in nursing infants, the manufacturer recommends that a decision be made whether to discontinue nursing or to discontinue sirolimus, taking into account the importance of the drug to the mother.

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